Tracheal tube and suction device

ABSTRACT

Tracheal tube systems may include first and second tubes and an inflatable balloon. The first tube may be flexible and hollow and have first and second open ends. The inflatable balloon may be affixed to and circumferentially surround a portion of the first tube. The inflatable balloon may include an indentation sized and positioned to accommodate a portion of a second tube positioned therein, when the inflatable balloon is inflated. The second tube may be hollow and have a multiplicity of holes along a sidewall not in contact with the balloon. The second tube may be configured to be coupled to a suction device that creates a negative pressure in the second tube. When the tracheal tube system is inserted in a patient&#39;s trachea, the negative pressure in the second tube may act to remove, or suction out, fluids and other matter from the trachea.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/511,012 filed Oct. 9, 2014 entitled “TRACHEAL TUBE AND SUCTIONDEVICE,” which is a continuation-in-part of U.S. patent application Ser.No. 14/149,403, filed Jan. 7, 2014 entitled “TRACHEAL TUBE,” which is acontinuation-in-part of U.S. patent application Ser. No. 14/051,443,entitled “TRACHEAL TUBE,” filed Oct. 10, 2013, both of which areincorporated herein by reference, in their entirety.

TECHNICAL FIELD

This specification generally relates to the field of tracheal tubes andsuction devices.

BACKGROUND

The subject matter discussed in the background section should not beassumed to be prior art merely as a result of its mention in thebackground section. Similarly, a problem and the understanding of thecauses of a problem mentioned in the background section or associatedwith the subject matter of the background section should not be assumedto have been previously recognized in the prior art. The subject matterin the background section may merely represents different approaches,which in and of themselves may also be inventions.

Tracheal tubes with inflatable balloons with suction means are broadlyknown in the prior art. However, the suctioning means of such prior artsare inefficient with suctioning secretions above and around the balloon,therefore allowing secretions and/or pathogens to travel through theballoon and tracheal walls and into the airflow of the tracheal tube. Incertain situations, the secretions/pathogens get aerosolized by the highvelocity of the ventilated air traveling through the tracheal tube andinto the patient's lungs. Aerosolized pathogens traveling at highvelocity may send the pathogens deep into the lungs, which may causeVentilator Associated Pneumonia (VAP).

BRIEF DESCRIPTION OF THE FIGURES

The present invention is illustrated by way of example, and notlimitation, in the figures of the accompanying drawings, in which:

FIG. 1 shows a diagram of an embodiment of a tracheal tube.

FIG. 2A shows a diagram similar to that of FIG. 1 but illustratinganother embodiment of a tracheal tube.

FIG. 2B shows a diagram yet another embodiment of a tracheal tube.

FIG. 3 shows a cross-sectional view of an embodiment of the catheter ofFIG. 1 taken longitudinally through the catheter along the 3-3 cut lineof FIG. 1.

FIG. 4 shows a cross-sectional view of an embodiment of a catheter and aballoon of FIG. 1 taken longitudinally through the catheter and theballoon along the 4-4 cut line of FIG. 1.

FIG. 5 shows a drawing of an embodiment of a balloon assembly.

FIG. 6A shows a flowchart of an embodiment of a method for inserting theendotracheal tube.

FIG. 6B shows a flowchart of an embodiment of a method for removing theendotracheal tube.

FIG. 7A shows a flowchart of an embodiment of a method for suctioningsecretion from the border of the cuff and trachea region.

FIG. 7B shows a flowchart of an embodiment of a method for rinsing fluiddispensing device is applying a rinsing fluid.

FIG. 7C shows a flowchart of an embodiment of a method for artificiallyventilating a patient.

FIG. 8 shows a flowchart of an embodiment of a method manufacturing atracheal tube.

FIG. 9 shows a flowchart of an embodiment of a method for manufacturinga tracheal tube.

FIG. 10 shows a flowchart of an embodiment of a method for creating aballoon.

FIG. 11 shows a flowchart of an embodiment of a method for attaching aballoon to the endotracheal tube.

FIGS. 12A and 12B show an embodiment of a tracheal tube.

FIG. 13 shows a drawing of an embodiment of a balloon assembly.

FIGS. 14A-14E show embodiments of shaped suction tubes.

FIGS. 15A and 15B show an embodiment of a tracheal tube.

FIGS. 16A and 16B show embodiments of exemplary ablative and cystoscopysurgery tools.

FIG. 17 shows a cross-section view of a patient with tracheal tubesystem positioned within his trachea.

SUMMARY

Tracheal tube systems may include first and second tubes and aninflatable balloon. The first tube may be flexible and hollow and havefirst and second open ends. The inflatable balloon may be affixed to andcircumferentially surround a portion of the first tube. The first end ofthe first tube is configured to be coupled to an artificial ventilationdevice and the first tube and may be configured so as to allow air orother gases provided by the artificial ventilation device to flowthrough the first tube into the lungs of an intubated (with the trachealtube system) patient.

The inflatable balloon may be positioned between the first and secondends of the first tube and include an indentation sized and positionedto accommodate a portion of a second tube positioned therein, when theinflatable balloon is inflated. In some embodiments, the indentation mayextend around a circumference, or a portion of a circumference, of theinflatable balloon.

In some embodiments, a portion of the indentation is positioned on theinflatable balloon coincident, or nearly coincident, with a junctionbetween the inflatable balloon and the first tube. The junction may bepositioned between the first end of the tube and the balloon.

The second tube may be hollow and have a multiplicity of holes along asidewall not in contact with the balloon. In some instances, the secondtube may be curved or pre-configured into a particular shape (e.g.,triangle, circle, etc.). The second tube may be flexible, rigid, or somecombination of both. In some circumstances, the second tube may be anassembly of two or more components. The second tube may be affixed tothe balloon within the indentation via, for example, a chemical- orheat-generated bond, a sleeve, a strap, and/or a clamp.

The second tube may be configured to be coupled to a suction device thatcreates a negative pressure in the second tube. On some occasions, thefirst tube may have a lumen coupled to the suction device and negativepressure in the lumen may cause negative pressure in the second tube.When the tracheal tube system is inserted in a patient's trachea, thenegative pressure in the second tube may act to remove, or suction out,fluids and other matter from the trachea. In some cases, when thetracheal tube system is placed in a trachea, the negative pressurecreated by the suction device may act to hold the second tube against aninner surface or wall of the trachea thereby preventing movement of thesecretions beyond the balloon and into the lower trachea or lungs.

In some embodiments, the indentation and the second tube may bepositioned relative to the inflatable balloon such that when thetracheal tube system is inserted into a trachea, the balloon isinflated, and negative pressure is applied to the second tube by thesuction device, the second tube is positioned against a portion of thetracheal wall, such as the posterior portion of the tracheal wall.

DETAILED DESCRIPTION

Although various embodiments of the invention may have been motivated byvarious deficiencies with the prior art, which may be discussed oralluded to in one or more places in the specification, the embodimentsof the invention do not necessarily address any of these deficiencies.In other words, different embodiments of the invention may addressdifferent deficiencies that may be discussed in the specification. Someembodiments may only partially address some deficiencies or just onedeficiency that may be discussed in the specification, and someembodiments may not address any of these deficiencies.

In general, at the beginning of the discussion of each of FIGS. 1-5 is abrief description of each element, which may have no more than the nameof each of the elements in the one of FIGS. 1-5 that is being discussed.After the brief description of each element, each element is furtherdiscussed in numerical order. In general, each of FIGS. 1-5 is discussedin numerical order and the elements within FIGS. 1-5 are also usuallydiscussed in numerical order to facilitate easily locating thediscussion of a particular element. Nonetheless, there is no onelocation where all of the information of any element of FIGS. 1-5 isnecessarily located. Unique information about any particular element orany other aspect of any of FIGS. 1-5 may be found in, or implied by, anypart of the specification.

FIG. 1 shows a diagram of an embodiment of a tracheal tube system 100.The tracheal tube system 100 may include at least one connector 102, acatheter 106 having opposed open proximal end 104 and open distal end122, a suction device 108A, an air dispenser device 108B, a fluiddispenser device 108C, a fluid reservoir 108D, at least one suction tube108E, at least one inflation tube 110A, a pilot balloon 110B, inflationfluid supplying device 110C, at least one suction tube lumen 112, atleast one inflation tube lumen 114, at least one suction line exit 116,at least one balloon 118, at least one suction line 120, at least oneenlarged opening 124, and at least one enlarged air passage way 126. Inother embodiments the tracheal tube system 100 may not have all of theelements or features listed and/or may have other elements or featuresinstead of or in addition to those listed. For example, the balloon 118may be closed at both ends (i.e., the portion of the balloon 118 closestto the open distal end 122 may be closed so as to seal off the enlargedair passageway 126.

The tracheal tube system 100 is a tracheal tube with a 360-degreesuction line and an enlarged airflow passage. In an embodiment,suctioning is set at 15 mm Hg negative pressure. The tracheal tubesystem 100 may be adapted to be used for various tubes such asendotracheal, endobronchial, and tracheostomy tubes. The tracheal tubesystem 100 is a catheter that is inserted into the trachea through themouth or nose in order to maintain an open air passage or to deliveroxygen, medications, or to permit the suctioning of mucus or to preventaspiration of oral secretions. Tracheal tube system tube 100 may be aflexible, hollow cylindrical tube that is open at both ends to allow airto pass through.

The connector 102 is a connection adapted to connect to a mechanicalventilator. The connector 102 attaches the tracheal tube system 100 to amechanical ventilator. In an embodiment, the connector 102 may have alength of 4 cm, a proximal Outer Diameter (OD) of 1.5 cm, a proximalInner Diameter (ID) of 1.3 cm, and a proximal length of 1.5 cm. Thecross-sectional area of the safety (which is the collar) is 1.5 cm×2.5cm. In an embodiment, the length of the safety is 0.5 cm. In anembodiment, the distal opening outer diameter (OD) of connector 102 is0.8 cm. In an embodiment, the distal length of connector 102 is 2 cm. Inan embodiment the tolerance for all of the listed dimensions in thisspecification is +/−10% of the value of the dimension in question. Inanother embodiment the tolerances in this specification is +/−5% of thedimension in question. In an embodiment, the connector 102 is made fromhard polypropylene. In other embodiments, the mechanical ventilator maybe replaced with an air bag if a mechanical ventilator is not available.

The proximal end 104 is the end of the tracheal tube system that is notintubated inside the patient. In this specification, to intubate apatient refers to placing a tube in the patient. For example, intubatinga patient may refer to the inserting a breathing tube into the tracheafor mechanical ventilation. The proximal end 104 is open and connectedto the end of the connector 102 opposite the mechanical ventilator. Inan embodiment, the proximal end 104 has a length of 31 cm. In anembodiment, the proximal end 104 is made from flexiblepolyvinylchloride.

The catheter 106 is a tube that is inserted into the body in order toaid delivery of medications. The catheter 106 may be inserted into thetrachea to deliver oxygen. The catheter 106 may be made from a tube. Thecatheter 106 may be made out of plastic (e.g., polyvinyl chloride, PVC).The plastic materials may be visually clear or opaque. Since plastic isnot radio opaque, the catheter 106 may have a line of radio opaquematerial that makes the tube more visible on a chest X-ray. In otherembodiments, the catheter 106 may be made out of wire-reinforcedsilicone rubbers. Yet in other embodiments, the catheter 106 may be madeout of silicone rubber, latex rubber, or stainless steel. The differentmaterials used to make a tracheal tube usually depend on the applicationof the tube that is required. For example, a wire-reinforced siliconerubber catheter is quite flexible yet difficult to compress or kink,making the wired-reinforced silicone rubber catheter useful forsituations in which the trachea is anticipated to remain intubated for aprolonged duration, or if the neck needs to remain flexible duringsurgery.

The catheter 106 may have an inner diameter and an outer diameter. The“size” of a tracheal tube refers to the inner diameter of the catheter.For example, if someone asks for a “size 6” tracheal tube, they areasking for a tracheal tube with an inner diameter of 6 mm. Furthermore,the inner diameter may be labeled on the catheter 106 as “ID 6.0.”Narrower tubes increase the resistance to gas flow. For example, a size4 mm tube has sixteen times more resistance to gas flow than a size 8 mmtube. The additional resistance can be especially relevant in thespontaneously breathing patient who will have to work harder to overcomethe increased resistance. Therefore, when choosing the appropriate“size”, the largest size that is suitable for a given patient istypically recommended. For human beings, the size of the catheter 106may range from 2.0 mm for neonates to 10.5 mm for adult males. Thecatheter 106 may have an OD of 0.7 cm to 0.9 cm (depending on the sizeof the patient).

The catheter 106 may have varying lengths depending on who or what isusing the catheter 106. The length of the catheter 106 is measured fromthe end that goes into the trachea. The length of the catheter may varyif the catheter 106 is inserted orally or through the tracheostomystoma. For human beings with an oral insertion, the length of thecatheter 106 may range from 7.5 cm for neonates to 23 cm for adultmales. In an embodiment, the catheter 106 may be inserted orally ornasally as an endotracheal tube.

In another embodiment, the catheter 106 may be inserted into atracheostomy stoma and used in a tracheostomy. A tracheostomy is anopening through the neck into the trachea through which a tube may beinserted to maintain an effective airway and help a patient breathe. Atracheostomy stoma is the actual opening. When the catheter is used in atracheostomy, the length of the catheter 106 may be shorter.

The primary channel 107 is the main passageway of the catheter 106 fordelivering gases containing oxygen to a patient or for extracting carbondioxide (CO₂) from a patient. The OD of primary channel 107 is variablefrom 0.6 cm to 0.8 cm. In an embodiment, the diameter of the primarychannel 107 is the same as the inner diameter of catheter 106.

The suction device 108A is a machine that can be used to remove mucousand other unwanted fluids from a patient. The suction device 108Acreates a negative pressure in order to extract mucous and otherunwanted fluids from a patient. The suction device 108A may have avarying power of suction. The suction device 108A may run continuouslyat a low power of suction setting to provide a constant suction. Thesuction device 108A may run on a periodic or as needed basis, dependingon the situation of application.

The air dispenser device 108B is a machine that can be used to pump airor other gases as well as aerosolized agents (e.g., pharmaceuticals).The air dispenser device 108B may be an electronically powered airdispenser or a manual air pump such as a syringe filled with air.

The fluid dispenser device 108C is a machine that is used to pump fluid.The fluid dispenser device 108C may be an electronically powered fluiddispenser with varying or fixed power of dispensing. The fluid dispenserdevice 108C may also be a manually operated device such as a syringefilled with a fluid.

The fluid reservoir 108D is a reservoir for storing rinsing fluid todispense into a patient to help loosen mucous build up to allow for aneasier extraction. The fluid reservoir may be water to be used as acleaning agent and/or may include another cleaning agent, or may besaline or an antibiotic rinse. The fluid reservoir 108D may be the fluidsource for the fluid dispenser device 108C. In some embodiments, fluiddispenser device 108C may not need to draw from the fluid reservoir of108D.

The suction tube 108E is a tube adapted to suction secretion collectedinside the border of the cuff and trachea region around the trachealtube. The border of the cuff and trachea region is the part of thecavity of the larynx below the true vocal chords. The suction tube 108Emay be adapted to connect to a suction device to suction the secretion.In some embodiments, the suction tube 108E may be attached to thecatheter 106 proximal to the open proximal end 104. In otherembodiments, the suction tube 108E may extend into the inner walls ofthe catheter 106. The suction tube 108E length is 24 cm. The suctiontube 108E may be made from flexible polyvinylchloride.

In another embodiment, the suction tube 108E may be adapted to connectto an air dispensing device 108B to dispense air into the suction tube108E to clear out the suction tube.

In yet other embodiments, the suction tube 108E may be adapted toconnect to a fluid dispenser device 108C to provide a rinsing fluid. Thefluid dispenser device may draw the rinsing fluid from the fluiddispensing reservoir 108D. The purpose of the rinsing fluid may be toloosen up the secretion and mucous surrounding the border of the cuffand trachea region around the trachea to loosen mucous, which maycollect around the tracheal tube. Once the rinsing fluid has beenintroduced, suction may be restored to the suction tube 108E and theliquid and any secretions that may have been loosened or dissolved maybe removed. The introduction of a rinsing fluid procedure may berepeated as deemed necessary and it is performed at the discretion ofthe caregiver or user in order to clean secretions and other liquidsthat may collect and potentially clog the suction. The rinsing fluid maycomprise water, saline, as well as other biocompatible liquids ormucolytic agents. A mucolytic agent is an agent, which dissolves thickmucus and is usually used to help relieve respiratory difficulties. Itdoes so by dissolving various chemical bonds within secretions, which inturn can lower the viscosity by altering the mucin-containingcomponents.

The inflation tube 110A is a tube used to supply an inflation fluid. Inan embodiment, the inflation tube 110A length is 24 cm. In anembodiment, the inflation tube is made from flexible polyvinylchloride.

The pilot balloon 110B is a balloon that provides an indication of theair pressure that exists in another balloon that it is connected to.Furthermore, the pilot balloon 110B has a one-way valve that preventsair inflated into the pilot balloon 110B from deflating because of theone-way valve design. The pilot balloon 110B may serve as a balloondeflator when the pilot balloon 110B is pressed, thus turning theone-way valve into a two-way valve.

The inflation fluid supplying device 110C is a device that delivers aninflation fluid. The inflation tube 110A may be connected to theinflation fluid supply device 110C by way of pilot balloon 110B. Thefluid supplying device 110C may be a syringe or a pump. The inflationfluid may be a gas or a liquid, depending on the desired functionalitiesof the inflation fluid. The inflation fluid may be air. The inflationfluid may also be a methylene blue colored saline. For example, someairway surgery involves the use of laser beams to burn away tissue.These beams can ignite ordinary endotracheal tubes and in the presenceof Oxygen may cause major airway fires. If the laser manages to damagethe balloon, the coloring will help identify rupture and the saline willhelp prevent an airway fire.

The suction tube lumen 112 is an extension of the suction tube 108E thatextends along the length of the catheter 106. The suction tube lumen 112further provides suction to the tracheal tube from the suction tube108E. The suction tube lumen 112 may be connected to the suction tube108E or it may be an extension of suction tube 108E that is connected tothe catheter 106. The suction tube lumen 112 may also extend along thelength and inside the walls of catheter 106. In another embodiment, thesuction tube lumen 112 may attach to the exterior surface of thecatheter 106 and extend along the length of the catheter 106. In otherembodiments, the suction tube lumen 112 may provide rinsing fluids fromthe suction tube 108E.

The inflation tube lumen 114 is an extension of the inflation tube 110Athat extends along the length of the catheter 106. The inflation tubelumen 114 may be connected to the inflation tube 110A. The inflationtube lumen 114 may also be an extension of the inflation tube 110A thatextends along the length and inside the wall of the catheter 106. Inanother embodiment, the inflation tube lumen 114 may attach to theexterior surface of the catheter 106 and extend along the length of thecatheter 106.

The suction lumen exit 116 is the point where the suction tube lumen 114emerges from the catheter 106. The suction lumen exit 116 isstrategically located along the length of the catheter 106 so that it isproximal to the location where secretion accumulates in the regionbordering the cuff and trachea above the balloon.

The balloon 118 is an inflatable resilient cuff. The balloon 118 servesas a seal between the tracheal tube and the patient's trachea wall toallow for positive pressure ventilation. Positive pressure ventilationis mechanical ventilation in which air is delivered into the airways andlungs under positive pressure, usually via an endotracheal tube,producing positive airway pressure during inspiration. The balloon 118may be made from various compositions of rubber or elastic polymerpolyurethane. The thickness and elasticity of the rubber material mayvary, depending on the intended use of the balloon 118/tracheal tubesystem 100. In an embodiment, the balloon 118 is 5 cm long and 3 cm indiameter. Excluding rare errors in calcium metabolism, most human maleand female trachea diameters fall between 25-29 mm and 23-27 mm,respectively. In an embodiment, the seal between each chamber is notcomplete so as to allow air to flow from one balloon to the next (theopening between chambers may be the width of the balloon and between0.1-0.5 cm high). In some embodiments, the balloon 118 may be a highpressure, low volume balloon. In other embodiments, the balloon 118 maybe a low pressure, high volume balloon. Depending on the intendedpurpose and use of the balloon, the appropriate material is used. Whenintroduced into the patient, the balloon 118 is initially deflated. Oncethe tracheal tube system 100 is placed inside the patient's trachea, theinflation tube 110A may be adapted to a fluid supplying device toinflate the balloon 118. The balloon 118 is connected to the inflationtube lumen 114. Once the balloon 118 is inflated, the shape and expandedsize of the balloon 118 creates a seal against the tracheal wall,thereby preventing gases being pumped into the lungs via the catheter106 from backing up around the tube and escaping through the trachealtube, thereby providing a positive pressure ventilation. The inflationof the balloon 118 creates a seal to provide a positive pressurenecessary to artificially ventilate the lungs.

The balloon 118 is attached to the catheter 106 between the suctionlumen exit 116 and the distal end 122. The balloon 118 is completelysealed to the catheter 106 at the end of the balloon distal to thesuction lumen exit 116. However, the opposite end of the balloon 118 isnot sealed to the catheter 106. Instead, the balloon 118 proximal to theopen distal end 122 is cylindrical shaped. The balloon, when notattached to a tracheal tube resembles the shape of a bottle without thebottom portion of the bottle. The shape of the balloon is created by theballoon's circular chambers and the size of chambers can vary, thelargest balloon is first and the size of the balloons decreases alongthe direction going towards the lungs. For example, in an embodiment,the balloon 118 diameters of the chambers, in order from proximal todistal, are 3 cm, 1 cm, 0.6 cm, 0.4 cm, 0.2 cm, and 0.1 cm,respectively.

In another embodiment, the balloon 118 may extend from the open distalend 122 along the length of catheter 106 and ending proximal to theconnector 102.

Tracheal tubes with balloon 118 may present a problem in that secretionsproduced above the balloon 118 may be prevented from flowing along thechannel of the esophagus or trachea and thereby collect above theballoon 118, providing a site for the possible accumulation ofpathogens. Occasionally, these pathogens may find their way through thecuff created by balloon 118 and end up below the cuff near the opendistal end 122. Once the pathogens make it through the balloon 118, thepathogens may find their way into the patient's lungs and create harmfulinfection. The accumulation of secretion above the balloon 118 maypresent other problems as well.

The suction line 120 is a tube with small holes distributed along asidewall of the tube. It is important to note that holes are onlythrough one sidewall of the suction line 120, as opposed to beingthrough both sidewalls of the suction line 120. The holes may bedistributed in any appropriate arrangement and may be, for example,arranged in a clustered or evenly distributed manner. Sidewalls of theholes may form any appropriate shape, such as a V-, U-, or square-typeshape. An opening in the suction line 120 formed by the holes may be ofany appropriate shape, such as, but not limited to a circle, an oval, asquare, a rectangle or any combination thereof. In an embodiment, thesuction line 120 is 1 cm in length. The small holes allow the suctionand removal of secretion fluid that comes in contact with the suctionline 120. The suction line 120 may be an extension of the suction tube108E and the suction tube lumen 112. The suction line 120 emerges fromwithin the catheter 106 walls at the suction lumen exit 116. Theconnection point between the balloon 118 and the catheter 106 proximalto the suction line 120 may be 0.5 cm-1.5 cm above the balloon 118 toensure a secure seal of the balloon 118 to the catheter 106. The suctionline 120 is wrapped around the catheter 106 and above the balloon 118.The suction line 120 wrap provides a 360 degree suction of secretionfluids that collect in the space above the balloon 118 and within thepatient's trachea (area bordered by the cuff and trachea) withoutnegatively impacting ventilation of the patient at the level of the cuffsuction line attached to balloon.

The suction line 120 may also wrap around the balloon 118. The suctionline 120 may wrap around the balloon 118 multiple times beforeterminating at a distal point of the exterior surface of balloon 118.The suction line 120 provides suction of secretions that collect in thespaces between the balloon 118 and the patient's trachea. The suctionline 120 may also provide additional sealing properties between theballoon and the tracheal wall within the patient when there is negativepressure within the suction line 120.

The suction line 120 may also coil around the balloon 118 withinpredefined sleeves on the balloon 118 outer surface. The sleeves will befurther discussed in FIGS. 5 and 12C.

In other embodiments, the suction line 120 may also distribute a rinsingfluid when the suction tube 108E is adapted to connect to a fluiddispensing device to dispense a rinsing fluid. The rinsing fluid flowsthrough the small holes dispersed along the suction line 120.

The open distal end 122 is the opening at the end of the tracheal tubesystem 100. In most embodiments, the open distal end 122 is the end thatresides inside the patient's tracheal area and the open distal end 122is where the mechanical ventilator's air, traveling through the primarychannel 107, may enter the patient's lungs. When the tracheal tubesystem 100 is intubated inside a patient, the open distal end 122 of thecatheter 106 is situated within the upper respiratory system of thepatient. In current use, the open distal end 122 serves as the primaryair passage way for mechanically ventilating a patient, with an openingin the sidewall of catheter 106 as the secondary source of air passagein the event the open distal end 122 is blocked. In the currentembodiment, the open distal end 122 will still serve as an air passageway.

The enlarged opening 124 provides an alternative air flow source to thepatient's lungs in the event the open distal end 122 is blocked orobstructed. The enlarged opening 124 serves as the primary source of airflow into the patient's lungs since the enlarged opening 124 has anopening considerably larger than the open distal end 122. The airflowfrom enlarged opening 124 comes into contact with the interior layer ofthe balloon 118. The inflated balloon 118 creates a cuff along thetracheal wall to prevent the escape of air pressure between thepatient's lung and the tracheal tube system 100. The airflow that comesout of the enlarged opening 124 may flow around the inner layer of theballoon 118 and get redirected towards the patient's lung. The enlargedopening 124 may have a length that is slightly longer along the lengthof the catheter 106 than the balloon 118 such that the opening 124 maystart from a point proximate to the 360 degree seal of the balloon 118with the catheter 106 proximal to the suction lumen exit 116 and extendbeyond the point where the balloon 118 ends proximal to the distal end122. The width of the enlarged opening 124 may be adjusted to create alarger cross sectional area of air flow to travel between the patient'slungs and the catheter 106.

In another embodiment, where the length of the balloon 118 may extendfrom proximal to the open distal end 122 along the length of catheter106 and terminate proximal to open proximal end 104, the length of theenlarged opening 124 may extend along the length of the entire catheter106 to provide a larger amount of area for airflow to travel between theprimary channel 107 and the patient's lungs.

The enlarged air passage way 126 is a passage way through which fluidspass between the patient's trachea and the tracheal tube system 100. Asize of the enlarged air passage way 126 may be determined by taking thecross-sectional area measured by the inner diameter of the inflatedballoon 118 and subtracting the cross-sectional area of the catheter106. The enlarged air passage way 126 allows the same amount of airvolume to move into the patient's lungs but at a slower velocity ascompared to prior devices.

The velocity at which a volume of air flows through a pipe may beincreased or decreased based on the diameter of the pipe. Decreasing theinput velocity increases particle size, decreases the aerosolization,and decreases micro speciation. The diameter of the pipe defines thecross-sectional area available for the volume of air to flow through.The velocity of a volume of air flows through a passage way may bereduced if the diameter of the passage way is increased. Likewise, whenthe diameter of the passage way is reduced, to move the same fixedvolume of air through the reduced diameter passage way, the velocity atwhich the volume of air flows must be increased to move the same fixedvolume of air through the reduced diameter passage way. The increaseddiameter of the passage way will increase the cross-sectional area forair to travel through. With a larger cross-sectional area for air totravel through the tracheal tube system 100 based on the enlarged airpassage way 126 created by the shape of the balloon 118 proximal to theopen distal end 122, the same volume of air that needs to flow into thelung(s) at the enlarged air passage way 126 may be delivered to thelung(s) at a reduced velocity. The volume of air that flows through fromthe enlarged opening 124 located within the balloon 118 is delivered tothe lungs through the enlarged air passageway 126. The reduction invelocity of airflow at the enlarged air passage way 126 helps to addressa common cause of issues with tracheal procedures, such as VentilatorAssociated Pneumonia (VAP). VAP can be minimized by eliminating the“aerosolization” of foreign bodies that shoot into the lower area of thelungs from the high speed of the ventilator. Currently, the“aerosolization” of foreign bodies traveling at high velocity into thelungs is due to the small cross sectional area of the traditionaltracheal tube. The smaller the cross sectional area of the tube, thehigher the velocity is required to move the same volume of air. Theenlarged air passage way 126 may allow the appropriate amount of air totravel into the patient's lungs at a reduced velocity of airflow that,in turn, may help to reduce a number of pathogens delivered to thelungs, which may cause VAP. In an embodiment, the length of the airpassage way 126 is 4.5 cm, whereas in contrast a standard Murphy's Eyeis 1.0 to 1.5 cm.

FIGS. 2A and 2B show a diagram similar to that of FIG. 1 butillustrating other embodiments of tracheal tube systems 200A and 200B,respectively. The tracheal tube systems 200A and 200B may include thefollowing elements, as explained in FIG. 1, at least one connector 102,a catheter 106 having opposed open proximal end 104 and open distal end122, a suction device 108A, an air dispenser device 108B, a fluiddispenser device 108C, a fluid reservoir 108D, at least one suction tube108E, at least one inflation tube 110A, a pilot balloon 110B, aninflation fluid supplying device 110C, at least one suction line 120, aplurality of enlarged opening 124, at least one enlarged air passage way126, and at least one balloon 218 a (FIG. 2A) or 218 b (FIG. 2B). Inother embodiments the tracheal tube systems 200A and 200B may not haveall of the elements or features listed and/or may have other elements orfeatures instead of or in addition to those listed.

Furthermore, the tracheal tube systems 200A and 200B may also include avocal chord crease 202. The vocal chord crease 202 is a portion of theballoon 118 that is narrow and extends for an amount necessary to clearthe vocal chords of the patient. The purpose of the vocal chord crease202 is to minimize contact between the tracheal tube systems 200A and200B and the patient's vocal chords. The balloon 218 a or 218 b in thecurrent embodiment extends along approximately the entire length of thecatheter 106. Other than the length of the balloon 218 a or 218 b andthe crease in the balloon 218 a or 218 b at the vocal chord crease 202,the balloon 218 a or 218 b is essentially the same as the embodimentdescribed in FIG. 1. No balloons are located in the crease to avoiddirect pressure on the vocal chords. The crease is suspended off thevocal cords by balloons on either end of the crease, and in anembodiment, the crease is color coded so that medical personnel can seewhere to position the crease.

The plurality of the enlarged openings 124 is the primary air flowchannel for the ventilation of the patient. The plurality of theenlarged openings 124 allows the velocity of the airflow between thepatient's lungs and the tracheal tube systems 200A and 200B to becomparable to the velocity of the airflow the patient would experiencewithout an artificial ventilation system.

In an embodiment, balloon 218 a or 218 b forms a tube surrounding andattached to catheter 106, which is open at both ends, so that air mayenter one end of the tube formed by balloon 118 and exit the other endof the tube formed by balloon 218 a or 218 b. When one end of trachealtube systems 200A or 200B is placed within a patient, air may enter thepatient via both the tube formed by balloon 218 a or 218 b,respectively, and catheter 106, so that air may enter and travel intothe patient through a larger cross sectional area than were balloon 218a or 218 b not present or crossed.

Tracheal tube systems 200A and 200B differ from one another in that thesections of balloon 218 a all have the same diameter, whereas thesections of balloon 218 b have decreasing diameters. In an embodiment,the largest segment of balloon 218 b has an outer diameter 5 cm, thenarrowest segment has an outer diameter of 1.5 cm, and the segments inbetween monotonically decrease in diameter from 5 cm to 1.5 cm goingform the end of the tracheal tube 200B that is furthest from the lungstoward the end that is closest to the lungs.

FIG. 3 shows a cross-sectional view 300 of an embodiment of the catheterof FIG. 1 taken longitudinally through the catheter at 3-3. Thecross-sectional view 300 may include an exterior surface 302, aninterior surface 304, a wall thickness 306, a catheter 106, suction tubelumen 112, inflation tube lumen 114, and primary channel 107.

The catheter 106, suction tube lumen 112, inflation tube lumen 114, andprimary channel 107 were discussed with regard to FIG. 1. The exteriorsurface 302 is the exterior surface of catheter 106. The interiorsurface 304 is the interior surface of the catheter 106. The wallthickness 306 is the tube thickness determined by the exterior surface302 and the inner surface 304. The thickness of the wall thickness 306may vary based on the different uses and application of the trachealtube system 100.

The suction tube lumen 112 may be an extension of the suction tube 108E(from FIG. 1) wherein the suction tube lumen 112 is configured to runalong the inside of the wall thickness 306. In another embodiment, thesuction tube lumen 112 may be attached to run along the exterior surface302 of the catheter 106.

The inflation tube lumen 114 may be an extension of the inflation tube110A (from FIG. 1) wherein the inflation tube lumen 114 is configured torun along the inside of the wall thickness 306. The inflation tube lumen114 may be situated opposite the suction tube lumen 112. In anotherembodiment, the inflation tube lumen 114 may be configured to run alongthe exterior surface 302 of the catheter 106.

FIG. 4 shows a cross-sectional view 400 of an embodiment of a catheter106 and a balloon 118 of FIG. 1 taken longitudinally through thecatheter 106 and the balloon 118 at 4-4. The cross-sectional view 400may include a spinal sealant 402, a balloon inner layer 404, a balloonthickness 406, and a catheter 106. Furthermore, cross-sectional view 400may also include a primary channel 107, a balloon 118, a suction line120, and an enlarged airway passage 126; all of which are furtherdefined in FIG. 1.

The spinal sealant 402 is the contact point along the outer surface ofthe catheter 106 and the inner surface of balloon 118. The balloon innerlayer 404 is the inner layer of the balloon 118. The balloon thickness406 is the thickness of the balloon 118 when fully inflated. The balloonthickness 406 may be a variable in the enlarged airway passage 126. Thethicker the balloon, the smaller the enlarged airway passage. Likewise,the thinner the balloon thickness 406, the larger the enlarged airwaypassage 126. The balloon thickness 406 may vary to provide theappropriate amount of enlarged airway passage 126. The spinal sealant402 is designed to not have any contact with the enlarged opening 124.

The spinal sealant 402 connection point may extend the length of thecatheter 106 (which is situated inside the balloon 118) to create asecure attachment between the balloon 118 and the catheter 106. In anembodiment, the spinal sealant 402 may be located opposite the enlargedopening 124 located on the catheter 106, so that the enlarged opening124 is not in contact with the inner wall of the balloon 118. The spinalsealant 402 may be glued to the inner walls of balloon 118. In anotherembodiment, the spinal sealant 402 may be heat infused by melting theinner wall of the balloon 118 along the spinal sealant 402 together. Theairflow that comes out of the enlarged Murphy's Eye will travel throughthe catheter 106 by way of the primary channel 107 and exit the catheter106 in one of two locations: 1) at the open distal end 122 or 2) at theenlarged opening 124. The air exiting the enlarged opening 124eventually flows through the enlarged air passage way 126.

FIG. 5 shows an embodiment of the balloon assembly 500. The balloonassembly 500 may include an outer balloon sheet 502, a plurality ofsleeves 504, an inner balloon sheet 506, a tube connection point 508, adistal edge 510, and an inflation connection point 514.

The outer balloon sheet 502 is the exterior layer of the balloon 118that comes into contact with the patient's tracheal walls. The outerballoon sheet 502 is generally a rubber material with various thicknessand elasticity, depending on the application of the balloon. Forexample, the balloon 118 may be adapted to be used in as a low volume,high pressure cuff or a high volume, low pressure cuff. In a low volume,high pressure application, the material of the balloon may be slightlythicker and less elastic whereas in a high volume, low pressureapplication, the material may be thinner and more elastic.

The plurality of sleeves 504 are like channels arranged parallel to oneanother in a diagonal configuration with respect to the outer balloonsheet 502. The sleeves 504 are aligned diagonally in such a way thatwhen the outer balloon sheet 502 is curled into a cylindrical shape, thesleeves 504 line up at the connection point to create a single helicalgroove around the cylindrical shape of the outer balloon sheet. Once thesleeves 504 are aligned, the sleeves may allow the suction line 120 towrap around the balloon 118 in an organized and predictable form becausethe suction line 120 fits neatly into the sleeves. Once the suction line120 is wrapped around the balloon 118 within the sleeves 504, thesuction line 120 may provide a slight protrusion over the balloonsurface. The protrusion provides a more secure and stable seal betweenthe balloon 118 and the patient's tracheal wall because the suctioneffect created by the suction line 120 around the balloon 118 helps tosecurely seal the balloon with the tracheal walls.

The inner balloon sheet 506 is the inner layer of the balloon 118. Theinner balloon sheet 506, when attached to the outer balloon sheet 502,allows the balloon 118 to take form. The tube connection point 508 isthe portion of the balloon 118 that attaches the balloon 118 to thetracheal tube. The tube connection point 508 is the only portion of theballoon 118 that attaches to the tracheal tube. The attachment is a 360degree tight seal around the tube. When the outer balloon sheet 502 andinner balloon sheet 506 are attached, the tube connection point 508 issealed tight to not allow any air to travel in between the two sheetbecause the purpose of the connection point 508 is attach the balloon118 to the tracheal tube.

The distal edge 510 is the edge of the outer balloon sheet 502 and innerballoon sheet 506 that is opposite the tube connection point 508. Thedistal edge 510 is the section of the outer and inner balloon sheetsthat is sealed together to create a balloon shape.

The longitudinal edge 512 is the edge that runs along the balloonlongitudinally. One end of the edge is the distal edge 510 and the otherend of the edge is the connection point 508. The longitudinal edge 512of the inner balloon sheet 506 will be the edge that seals to theopposing longitudinal edge 512 of the inner balloon sheet 506 to createa cylindrical shape for the inner balloon sheet 506. Likewise, thelongitudinal edge 512 of the outer balloon sheet 502 will be the edgethat seals the opposing longitudinal edge 512 of the outer balloon sheetto create a cylindrical shape for the outer balloon sheet 502. The outerballoon sheet 502 is slightly larger than the inner balloon sheet 506 sothat the cylindrical shape of the outer sheet may fit on the outside ofthe cylindrical shape of the inner sheet. The sleeves 504 are outwardfacing on the outside of the outer balloon sheet's cylindrical form.

The inflation connection point 514 is where the balloon's inflationfluid enters and exists to inflate and deflate the balloon 118respectively. The inflation connection point 514 connects to theinflation tube lumen 114 (FIG. 1). The inflation connection point 514may be a hole or it may be an actual small valve connector to connect tothe inflation tube lumen 114. In other embodiments, it may just be amarking on the inner balloon sheet to provide guidance to create a holeupon assembly and attachment of the balloon 118 to the catheter 106.

The sleeves 504 on the balloon 118 will create a channel to allow thesuction line wrap 114 to remain securely attached to the balloon 118.Once the balloon 118 is inflated, the suction line wrap 114 fitssecurely in the helical sleeve 504 (FIG. 5) on the balloon 118. Thesuction line wrap 114 provides a slight protrusion over the balloonsurface to provide a more secure and stable seal of the balloon and thetracheal tube system 100 within the patient because the slightprotrusion is that of the suction line wrap 114. The suction effectcreated by the suction line wrap 114 around the balloon 118 helps tosecurely seal the balloon with the tracheal walls

The balloon 118 is shaped by fusing the two layers of the balloon sheetstogether where the outer balloon sheet 502 will have a sleeve 504 toallow the suction line 120 to lie within. One end of the balloon 118 iscompletely sealed to the catheter 106 proximal to suction line 120. Theother distal end of the balloon will not be completely sealed to thecatheter 106. Instead, the inner balloon layer 506 will be attached tothe spine portion of the catheter 106 as displayed as the spinal sealant402 (FIG. 4).

FIG. 6A shows a flowchart of an embodiment of method 600 a in which acaregiver is intubating a patient. Initially, the caregiver determinesthat a patient needs an advance airway orally and then, in step 604, thecaregiver opens the patient's mouth to begin the intubation process. Instep 606, the caregiver pushes the patient's jaw forward to create anadequate opening to perform the intubation.

In step 608, the caregiver may use a laryngoscope as a guide to placethe endotracheal tube above the epiglottis. The caregiver may also use aglideslope to assist with the intubation process. In some situations,where no guiding tools are available, the caregiver may intubate blindlyif the situation requires immediate intubation. A laryngoscope is amedical device that is used to obtain a view of the vocal folds and theglottis. Laryngoscopy (larynx+scopy) may be performed to facilitatetracheal intubation. A glidescope is the first commercially availablevideo laryngoscope. The glidescope incorporates a high resolutiondigital camera, connected by a video cable to a high resolution LCDmonitor. It may be used for tracheal intubation to provide controlledmechanical ventilation. When using the laryngoscope or glidescope tofacilitate intubation, the caregiver should exercise special care toidentify the vocal chords in order to properly intubate the trachealtube to prevent contact between the balloon 118 and the vocal chords. Ifthe caregiver does not properly intubate the tracheal tube below thevocal chord and if upon inflation of the balloon 118 the cuff expandsonto the vocal chord, it may damage the patient's vocal chords. Extracare must be exercised to ensure the intubation is performed correctlyand the vocal chords are clear of contact by the balloon once theballoon 118 is inflated. An aluminum stylet may be used to provide theflexible endotracheal tube with some support and stiffness to assistwith the intubation process.

In step 610, the caregiver places the tracheal tube into place properlywithout causing injury. Injuries may include breaking teeth or damagingvocal chords and would not include trauma that may be expected with theintubation process. In step 612, once the intubation is complete, thecaregiver removes the aluminum stylet from the tracheal tube.

In step 614, the caregiver inflates the balloon with air by attaching asyringe or any other fluid providing device that may be required toinflate the balloon. In some embodiments, air may be the fluid ofchoice. In other embodiments, a liquid based fluid may be used. When theballoon is inflated, the coiled suction line 120 form fits into thesleeves on the outside of the balloon.

The caregiver then deploys the suction line 120 and the balloon isinflated to the tracheal border.

In step 616, the caregiver connects the suction tube 108E to a suctiondevice 108A to provide a constant stream of suction to the regionbordered by the cuff and trachea above the balloon 118. The suctiondevice may have a suction power adjustable knob to set a desiredsuction. By connecting the suction tube 108E to the suction device 108A,the removal of secretion build up located above the balloon 118 andbetween the tracheal walls and the balloon may continue indefinitelywithout the need for a caregiver to constantly monitor the patient forsecretion build up.

The suction line 120 creates a seal between the balloon 118 and thetrachea.

In an embodiment, each of the steps of method 600 a is a distinct step.In another embodiment, although depicted as distinct steps in FIG. 6A,steps 604-617 may not be distinct steps. In other embodiments, method600 a may not have all of the above steps and/or may have other steps inaddition to or instead of those listed above. The steps of method 600 amay be performed in another order. Subsets of the steps listed above aspart of method 600 a may be used to form their own method.

FIG. 6 shows a flowchart of an embodiment of method 600 b in which acaregiver is removing an endotracheal tube. In step 652, the caregiverdeflates the balloon 118 by pressing the pilot balloon 110B. In step654, the caregiver carefully removes the endotracheal tube from thepatient orally.

In an embodiment, each of the steps of method 600 b is a distinct step.In another embodiment, although depicted as distinct steps in FIG. 6B,step 652-654 may not be distinct steps. In other embodiments, method 600b may not have all of the above steps and/or may have other steps inaddition to or instead of those listed above. The steps of method 600 bmay be performed in another order. Subsets of the steps listed above aspart of method 600 b may be used to form their own method.

FIG. 7A shows a flowchart of an embodiment of method 700 a in which asuctioning device is suctioning secretion from the region bordered bythe cuff and trachea. In step 702, the suction tube 108E is connected toa suction device 108A. In step 704, the negative pressure within thesuction tube 108E is transferred through the suction tube lumen 112 tothe suction line 120. In step 706, the negative pressure creates anegative pressure/suction at the suction holes throughout the suctionline 120. In step 708, the accumulated secretions are suctioned throughthe suction holes for disposal. In step 710, the negative pressurewithin the suction line creates a seal between the balloon 118 and thepatient's tracheal wall. The secretions may be collected for samples forculture for diagnosing and monitoring.

In an embodiment, each of the steps of method 700 a is a distinct step.In another embodiment, although depicted as distinct steps in FIG. 7A,step 702-710 may not be distinct steps. In other embodiments, method 700a may not have all of the above steps and/or may have other steps inaddition to or instead of those listed above. The steps of method 700 amay be performed in another order. Subsets of the steps listed above aspart of method 700 a may be used to form their own method.

FIG. 7B shows a flowchart of an embodiment of method 700 b in which arinsing fluid dispensing device is applying a rinsing fluid. In step742, the suction tube 108E is connected to a rinsing fluid dispenserdevice 108C. In step 744, the rinsing fluid travels through the suctiontube 108E, the suction tube lumen 112, and the suction line 120. In step746, the rinsing fluid is dispersed through the suction holes on thesuction line 120. The rinsing fluid is allowed to momentarily interactwith the mucous and area bordered by the cuff and trachea. Depending onthe rinsing fluid used, the mucous may be loosened to allow it to beeasily extracted. In step 748, the suction tube 108E is reconnected to asuction device 108A to remove the rinsing fluid and any other secretionthat may have collected during the rinsing fluid administering process.

In an embodiment, each of the steps of method 700 b is a distinct step.In another embodiment, although depicted as distinct steps in FIG. 7B,step 742-748 may not be distinct steps. In other embodiments, method 700b may not have all of the above steps and/or may have other steps inaddition to or instead of those listed above. The steps of method 700 bmay be performed in another order. Subsets of the steps listed above aspart of method 700 b may be used to form their own method.

FIG. 7C shows a flowchart of an embodiment of method 700 c in which amechanical ventilator is artificially ventilating a patient. In step762, a tracheal tube system 100 is connected to a mechanical ventilatorvia connector 102. In step 764, the mechanical ventilator pumps air toand from the patient's lung(s) by way of a primary channel 107, theenlarged opening 124, and the open distal end 122. The velocity ofoxygen and air flowing into the patient's lungs is reduced as a resultof the enlarged opening 124 and the enlarged air passage way 126.

In an embodiment, each of the steps of method 700 c is a distinct step.In another embodiment, although depicted as distinct steps in FIG. 7C,step 762-764 may not be distinct steps. In other embodiments, method 700c may not have all of the above steps and/or may have other steps inaddition to or instead of those listed above. The steps of method 700 cmay be performed in another order. Subsets of the steps listed above aspart of method 700 c may be used to form their own method.

FIG. 8 shows a flowchart of an embodiment of method 800 in which atracheal tube of system 100 is manufactured. In step 802, a trachealtube is made. In step 804, a balloon 118 is made, which involves thestep of making the balloon 118. In step 806, the balloon 118 is attachedto the tracheal tube from step 802. In other embodiments of method 800,step 804 may be performed before step 802. However, step 806 requiresthat step 802 and step 804 be performed in order to attach the trachealtube and the balloon 118.

In an embodiment, each of the steps of method 800 is a distinct step. Inanother embodiment, although depicted as distinct steps in FIG. 8, step802-806 may not be distinct steps. In other embodiments, method 800 maynot have all of the above steps and/or may have other steps in additionto or instead of those listed above. The steps of method 800 may beperformed in another order. Subsets of the steps listed above as part ofmethod 800 may be used to form their own method.

FIG. 9 shows a flowchart of an embodiment of a method for implementingstep 802 in which a tracheal tube system 100 is manufactured. In step902, a tracheal tube is made, which may include making a catheter 106from a plastic (polyvinyl chloride, PVC) material with 3 lumencomprising a suction tube 108E, an inflation tube 110A and a primarychannel 107. In other embodiments, other types of material may be usedto make the catheter 106 such as wire-reinforced silicone, siliconerubber, latex rubber, or stainless steel. The length, diameter, andthickness of the catheter 106 may vary depending on the size of thecatheter being created for the various ages, genders and sizes of atargeted user base. The suction tube 108E and inflation tube 110A arebuilt into the wall of the catheter 106. In other embodiments, thesuction tube 108E and inflation tube 110A may be tubes attached on theouter surfaces of catheter 106.

In step 904, make a suction lumen exit 116. The suction lumen exit 116is an exit hole at the distal end of the suction tube 108E proximal tothe balloon 118. The suction lumen exit 116 may be located slightlyabove the point where the balloon 118 will be attached to the catheter106.

In step 906, a bevel cut is made at open distal end 122. The bevel shapeof the catheter 106 helps with the intubation process of the trachealtube.

In step 908, an enlarged opening 124 is made. Step 908 involves cuttingan elongated oval shaped opening proximal to the open distal end 122 onthe top side of the catheter 106. The length of the enlarged opening 124is extended along the length of the catheter 106 starting proximal tothe open distal end 122 and extending proximal to the suction lumen exit116.

In step 910, an inflation tube 110A, suction tube 108E, and suction line120 is attached to the catheter 106. An inflation tube 110A is attachedto the inflation tube lumen 114 on one end and to a pilot balloon 110Bon the opposite end. In another embodiment, inflation tube 110A may bean extension of inflation tube lumen 114 and a part of step 902. Inother embodiments, pilot balloon 110B may be attached to the inflationtube prior to intubation.

A suction tube 108E is attached to the suction tube lumen 112. Inanother embodiment, suction tube 108E may be an extension of suctiontube lumen 112 and a part of step 902.

A suction line 120 is attached to the suction lumen exit 116. Thesuction line 118 may be similar to the suction tube 108E in material,shape, and diameter. However, the suction line 120 contains many smallholes distributed throughout the suction line 120 in order to providefluid transmission in and out of the suction line 120. In anotherembodiment, the suction line 120 may be an extension of the suction tubelumen 112 and a part of the suction lumen exit 116.

A preformed balloon cuff may be attached to the balloon 118.

In an embodiment, each of the steps of method 802 is a distinct step. Inanother embodiment, although depicted as distinct steps in FIG. 9, step902-910 may not be distinct steps. In other embodiments, method 802 maynot have all of the above steps and/or may have other steps in additionto or instead of those listed above. The steps of method 802 may beperformed in another order. Subsets of the steps listed above as part ofmethod 802 may be used to form their own method.

FIG. 10 shows a flowchart of an embodiment of a method of implementingstep 804 in which a balloon is manufactured. In step 1002, an outerballoon sheet 502 is made using a flexible rubber based thin sheet thatis generally used in balloon manufacturing for endotracheal tubes. Theouter balloon sheet 502 comprises a plurality of sleeves 504 arrangeddiagonally across the sheet to serve as channels for the suction line120 to fit into when the balloon 118 is inflated. The diagonally alignedsleeves on the outer balloon sheet 502, when curled lengthwise andattached, creates a helical groove for the suction line 120. The shapeof the outer sheet is displayed in FIG. 5.

In step 1004, an inner balloon sheet 506 is made using a similarmaterial as the material used in step 1002 when making the outer balloonsheet 502. The inner balloon sheet 506 is the same shape as the outerballoon sheet 502. The inner balloon 506 does not contain sleevesarranged diagonally across the sheet.

In step 1006, the inner balloon sheet 506 is curled into a cylindricalshape and sealed along the longitudinal edge 512. In step 1008, theouter balloon sheet 502 is curled into a cylindrical shape and sealedalong its longitudinal edge 512.

In step 1010, the outer balloon sheet 502 and inner balloon sheet 506are sealed to one another along the distal edge 510 and the balloonconnection point 508. The outer balloon sheet 502 is on the outside ofthe connection with the sleeves 504 facing outwards. The balloonconnection point 508 is sealed completely to ensure there will be nospaces for air to inflate in connection point 508 area of the balloonassembly.

In an embodiment, each of the steps of method 804 is a distinct step. Inanother embodiment, although depicted as distinct steps in FIG. 10, step1002-1010 may not be distinct steps. In other embodiments, method 804may not have all of the above steps and/or may have other steps inaddition to or instead of those listed above. The steps of method 804may be performed in another order. Subsets of the steps listed above aspart of method 804 may be used to form their own method.

FIG. 11 shows a flowchart of an embodiment of a method for implementingstep 806 in which a balloon is attached to a tracheal tube. Theattachment of the balloon 118 assembled from step 804 and tracheal tubeassembled from step 802. In step 1102, the balloon 118 is attached tothe tracheal tube assembled from step 802 by inserting the distal end122 through the balloon 118 from the connection point 508 towards thedistal edge 510. The connection point 508 is sealed completely aroundthe catheter 106 proximal to the suction lumen exit 116 without cominginto contact with the suction lumen exit 116.

In step 1104, the inner surface of the balloon 118 is sealed to thespinal length of the catheter 106 along the spinal seal 402. The spinalseal 402 does not contact or obstruct the enlarged opening 124. Theinflation tube lumen 114 is connected to the balloon 118 at theinflation connection point 514. In step 1106, the suction line 120 iscoiled around the catheter 106 from the suction lumen exit 116 towardsthe distal end 122. The suction line 120 is further coiled around thedeflated balloon 118 guided by the helical groove created by the sleeves504.

In step 1108, the suction line 120 is attached to the outer surface ofthe distal end of balloon 118. The attached point may be proximal alongthe distal edge 510 of the balloon, without actually coming into contactwith the sealed distal edge 510.

In an embodiment, each of the steps of method 806 is a distinct step. Inanother embodiment, although depicted as distinct steps in FIG. 11, step1102-1108 may not be distinct steps. In other embodiments, method 806may not have all of the above steps and/or may have other steps inaddition to or instead of those listed above. The steps of method 806may be performed in another order. Subsets of the steps listed above aspart of method 806 may be used to form their own method.

FIGS. 12A and 12B illustrate an alternative embodiment of tracheal tubesystem 100; tracheal tube system 1200. More specifically, FIG. 12Aillustrates a side view of tracheal tube system 1200 and FIG. 12Billustrates a front view of tracheal tube system 1200.

In tracheal tube system 1200, both ends of the balloon 118 are joined tothe catheter 106 so that air, or other gasses, does not escape from theballoon 118. The balloon 118 includes an indentation 1210 shaped andpositioned to accommodate placement of a portion of suction line 120thereon. Indentation 1210 may be positioned so as to correspond to aportion of the balloon 118 furthest away from the open distal end 122and may be sized to accommodate positioning of the suction line 120circumferentially over an upper portion of an exterior surface of theballoon 118 (i.e., away from the open distal end 122) as shown in FIGS.12A and 12B. For example, indentation 1210 may be sized so as toaccommodate positioning of the suction line 120 circumferentially over60°-270° (i.e., 16.7%-75%) of the upper exterior surface of the balloon118.

In some embodiments, indentation 1210 may act to guide the shape and/orpositioning of the suction line 120 into a desired configuration, whilein other embodiments, suction line 120 may be pre-configured by, forexample, a molding process, to be shaped to fit within indentation 1210.For illustrative purposes, the indentation depicted in FIGS. 12A and 12Bis configured to accommodate a triangular-shaped shaped suction line 120as described below with regard to FIG. 14A. However, it will beappreciated by those of skill in the art that indentation 1210 may besized, shaped, and/or positioned to accommodate any number of shapedsuction lines 120, such as the exemplary shaped suction lines 120 ofFIGS. 14B-14E as described in greater detail below.

FIG. 13 illustrates an alternative embodiment of the balloon assembly500; balloon assembly 1300. Balloon assembly 1300 shows an exemplaryballoon assembly with indentation 1210, tube connection point 508,distal edge 510, and inflation connection point 514. In some cases,aspects of indentation 1210 may resemble sleeves 504 as discussed abovewith regard to FIG. 5, such that when the balloon 118 is assembled,indentation 1210 is positioned thereon. Additionally, the balloonassembly 1300 may be assembled to create balloon 118 in a manner similarto that described with regard to FIG. 5.

FIGS. 14A-14E illustrate various exemplary configurations for thesuction line 120. In some instances, the suction line 120 may be madefrom a rigid and/or flexible material and may be a one-piece ormulti-piece construction. The suction line 120 may be configured intoany appropriate shape. In some instances, the suction line 120 may bepre-configured to have a particular shape and/or may assume a particularshape as a result of being positioned within an indentation, such asindentation 1210. For example, suction line 120 may be configured into atriangular-type shape as shown in FIG. 14A or a curved serpentine-typeshape as shown in FIG. 14B. In the embodiments of FIGS. 14A and 14B, thesuction line 120 may be pre-molded to adopt the shape of indentation1210. The suction lines 120 of FIGS. 14A and 14B may have any number ofholes 1410 by which fluid and other material may be removed from apatient's trachea by negative pressure applied by the suction line 120via holes 1410. Holes 1410 may be placed in the suction line 120 in auniform, clustered, and/or random pattern as may be appropriate for aparticular application.

In some embodiments, the suction line 120 may have a flattenedplanar-type component as shown in FIGS. 14C and 14D with holes 1410arranged thereon. FIG. 14C shows a flattened planar component 1420 ofthe suction line 120 with holes 1410 arranged in a random pattern andFIG. 14D shows a flattened planar component of the suction line 120 withholes arranged along an edge of the flattened planar component. Theflattened planar component of FIG. 14D may also include channels orgrooves 1425, which may be configured and/or arranged so as to assistwith direction of fluids and secretions to the holes 1410 for eventualsuction away from the trachea by negative pressure applied to the fluidssupplied by the suction line 120.

FIG. 14E depicts an exemplary suction line 120 configured in anexemplary triangular-type shape with a plurality of suction protrusionsor suction ports 1430. It is important to note that suctionprotrusions/ports 1430 are not drawn to scale in FIG. 14E and may extendfrom suction tube 120 by, for example, a few micrometers (e.g., 5 or 10micrometers) to a few millimeters (e.g., 0.5-5 mm). Suctionprotrusions/ports 1430 may extend from the suction line 120 in order to,for example, facilitate the application of negative pressure to acontacted tissue, fluid, or other substance.

FIGS. 15A and 15B illustrate the tracheal tube system 1200 with a shapedsuction line 120 positioned within indentation 1210. More specifically,FIG. 15A illustrates a side view of tracheal tube system 1200 with theshaped suction line 120 positioned within indentation 1210 and FIG. 12Billustrates a front view of tracheal tube system 1200 with the shapedsuction line 120 positioned within indentation 1210.

For illustrative purposes, FIGS. 15A and 15B show the triangular-shapedshaped suction line 120 of FIG. 14A as being positioned withinindentation 1210, however, it will be appreciated by those of skill inthe art that indentation 1210 may be sized, shaped, and/or positioned toaccommodate any number of shaped suction lines 120.

In some embodiments, the suction balloon 118 may not include apre-fabricated indentation 1210 and, in these embodiments, the suctionline 120 may be positioned on a surface of the balloon 118. On someoccasions, in these embodiments, the suction line 120 may formindentation 1210 by, for example, pressing down on a portion of theinflated balloon 118 when the tracheal tube system 1200 or 100 isinserted into a trachea.

As described herein, positioning suction line 120 on a surface ofballoon 118 may include embodiments wherein suction line 120 (or aportion thereof) is permanently affixed to balloon 118 via, for example,a chemical, pressure, and/or heat generated bond. In other embodiments,suction line 120 may be positioned on a surface of balloon 118 via aflexible bond created by, for example, a flexible glue and/or lubricant.Further, the suction line 120 may removably positioned on a surface ofballoon 118 via a simple placement of suction line 120 on the surface ofthe balloon 118 (i.e., no bond, or only a friction bond, between thesurface of the balloon 118 and the suction line 120). Additionally, thesuction line 120 may be positioned and/or held within indentation 1210via a retention apparatus like a continuous or intermittent sleeve orclamp and/or one or more straps. In some instances, the sleeve(s),clamp(s) and/or strap(s) may be laid on top of a positioned suction line120 so as to keep the suction line 120 in place. Additionally, in somecircumstances, a portion of suction line 120 may be held in place by atracheal wall in which the tracheal tube system 1200 is placed.

The suction line 120 may be positioned on the balloon 118 such that theholes 1410 therein are not in contact with a surface of the balloon 118.In this way, the holes 1410 may face outward (relative to the surface ofthe balloon 118) such that when inserted into a trachea, the holes 1410are in contact, or are nearly in contact, with the tissue of thetracheal opening so as to facilitate evacuation of fluid or othersubstances from a patient's trachea by the application of negativepressure via the suction line 120.

FIGS. 16A and 16B illustrate a tip end of an exemplary ablative surgicaltool 1610 and a cystoscopy surgical tool 1615 that carry an ablative tip1620 and a cautery tip 1625, respectively, both of which have a suctionline 120 affixed thereto. Ablative and cystoscopic surgical tools areknown in the art as tools for performing surgical procedures thatinvolve the burning of undesirable tissue (e.g., cancerous or cystic)with an ablative or cauterizing tip, such as ablative tip 1620 andcauterizing tip 1625, so as to remove the undesirable tissue from thebody of a patient. An undesirable byproduct of the use of ablativeand/or cauterizing surgical techniques is the production of smoke aswell as tissue fragments and liquids (e.g., blood, puss, etc.) thatvisually obscure the surgical field. Traditional methods of removingthese ablative/cautery byproducts involve removal of theablative/cystoscopy surgical tool from the surgical cavity so that asuction device (typically a surgical suction cannula) can be insertedinto the surgical cavity to remove the ablative/cautery byproducts.

However, ablative and cystoscopy surgical tools 1610 and 1615 have asuction line 120 affixed thereto so that ablative/cauterizing byproductscan be removed from the surgical cavity as they are generated bynegative pressure applied via either holes 1410 and/or and an open, orpartially open, end of suction line 120. Affixation of the suction line120 to the ablative and cystoscopy surgical tools 1610 and 1615 may actto reduce the time to perform the surgery and trauma to tissuessurrounding the surgical site caused by the repeated insertion andremoval of the ablative or cystoscopy surgical tools and suction devicesinto/out of the surgical cavity as would be necessary to traditionallyperform ablative or cystoscopic surgery. Additionally, or alternatively,affixation of the suction line 120 to the ablative and cystoscopysurgical tools 1610 and 1615 may act to improve visibility whenperforming ablative and cystoscopy surgical procedures by continuously,or nearly continuously, removing smoke, ash, tissue fragments, and/orliquids from the surgical field.

It will be appreciated by those of skill in the art that many types ofsurgical tools (scalpels, endoscopes, micro-scissors, clamps, etc.) maybenefit from having a suction line, like suction line 120 affixedthereto to assist with the removal of, for example, tissue, liquid,blood, and/or smoke from the surgical field thereby improving the degreeof visibility in the surgical field when performing a surgicalprocedure.

FIG. 17 is a cross-section view of a patient with tracheal tube system1200 positioned within his trachea 1720. It should be noted that FIG. 17is not drawn to scale. In the embodiment of FIG. 17, an assembly ofballoon 118, indentation 1210, and suction line 120 are positioned belowthe patient's vocal cords 1710. The assembly may be positioned so thatsuction line 120, or a portion thereof, is in contact with a posteriorportion of the tracheal wall 1725 for the evacuation of fluids,excretions, etc. from the trachea that may otherwise gather or pool onthe posterior wall of the trachea 1720 due to gravitational forceapplied thereto. In some instances, it may be preferable to position thetracheal tube system 1200 assembly so that an upper junction betweenballoon 118 and catheter 106 may be located below (e.g., 0.1 cm-1.5 cm)the vocal cords 1710. Preferably, the upper junction is located 0.5 cmbelow the vocal cords 1710.

Hence, tracheal tubes, tracheal tube systems, and surgical tools withand suction devices attached thereto have been herein described. Thenegative pressure, or suction, applied (continuously, periodically, oron an as needed basis) by various embodiments of the tracheal tubesdescribed herein extract pooling liquid and secretions as well aspathogens and foreign matter, which may serve as a breeding ground forbacteria and viruses and a collection agent for aerosolized pathogens,from a patient's trachea while intubated with any of the tracheal tubesherein described. Extraction of the pooling liquid and secretions fromthe trachea may serve to decrease instances of VAP and other diseasesbecause they do not travel beyond the suction line 120 and into thelungs.

Additionally, use of the tracheal tubes disclosed herein may serve todecrease discomfort typically associated with being intubated with atraditional tracheal tube because the suction and negative pressureapplied by the suction line 120 is dispersed across the multiplicity ofholes along suction line 120 and is not focused on a single hole. As aresult, the amount of suction/negative pressure applied to a particulartracheal location used to remove secretions and other liquids isrelatively small when compared to the amount of suction/negativepressure applied to only one location in the trachea (as would be thecase with a single suction hole). This is clinically significant becausethe force exerted on the tracheal tissue is dispersed over a largersurface area. Consequently, the force exerted on any one point oftracheal tissue is less and, in this way, trauma and discomfort that maybe caused by the exertion of force on the tracheal tissue is reduced.This enables negative pressure or suction to be applied to the tracheafor a longer period of time without causing damage to sensitive trachealtissues and irritation and discomfort to the patient.

In addition, embodiments of the tracheal tubes described herein may bedeployed within a trachea of a patient regardless of the orientation ofthe patient (e.g., supine, prone, or on a side). For example, for thetracheal tube systems 100, 200A, and 200B, the suction line 120 wrapsaround the entire circumference of the balloon 118 and, as such, canapply negative pressure or suction to the tracheal walls regardless ofthe orientation of an intubated patient or the orientation of thetracheal tube when positioned within the patient. Additionally, for thetracheal tube embodiments 1200, the indentation 1210 and suction line120 wrap around a partial circumference of the balloon 118 (from 60° to270°) and, depending on the size of the portion of the circumference ofthe balloon 118 covered by the indentation 1210 and suction line 120,the suction line 120 can apply negative pressure or suction to thetracheal walls of the patient to extract pooling liquid and othermaterials regardless of the orientation of an intubated patient or theorientation of the tracheal tube when positioned within the patient,with the possible exception of a patient who is oriented in theopposition direction as the tracheal tube 1200, in which case gravitywould cause the liquid/other material to pool on a portion of thetracheal wall not contacted by, or sufficiently close to, the suctionline 120 (e.g., if a patient is lying prone and the indentation 1210 andsuction line 120 are oriented toward the posterior side of the patient).However, the occurrence of this exception is clinically rare and, if itwere to occur, the tracheal tube 1200 could be slightly rotated so as tobe positioned to provide negative pressure to fluids and other materialsthat may pool on the anterior portion of the tracheal wall.

Furthermore, the suction line 120 of the tracheal tube embodimentsdisclosed herein may act to maintain a desired position for the trachealtube once inserted into a patient by adhering to the tracheal wall and,thereby, preventing slipping of the tracheal tube along the trachea.

Each embodiment disclosed herein may be used or otherwise combined withany of the other embodiments disclosed. Any element of any embodimentmay be used in any embodiment.

Although the invention has been described with reference to specificembodiments, it will be understood by those skilled in the art thatvarious changes may be made and equivalents may be substituted forelements thereof without departing from the true spirit and scope of theinvention. In addition, modifications may be made without departing fromthe essential teachings of the invention.

We claim:
 1. A tracheal tube system comprising: a first tube that isflexible and hollow and having a first open end and a second open end;an inflatable balloon affixed to, and circumferentially surrounding anexterior portion of the first tube, the inflatable balloon beingpositioned between the first open end and the second open end of thefirst tube; and a second tube, the second tube being hollow and having amultiplicity of holes along a sidewall of the second tube, the secondtube being substantially perpendicular to the first tube, positionedabove the inflatable balloon, and surrounding a portion of the firsttube, wherein the second tube is configured to be coupled to a suctiondevice that creates a negative pressure in the second tube and thesecond tube is positioned such that when the tracheal tube system isinserted into a trachea, the inflatable balloon is inflated, andnegative pressure is applied to the second tube by the suction device,the second tube is positioned against a portion of a tracheal wall. 2.The tracheal tube system of claim 1, wherein the second tube is curved.3. The tracheal tube system of claim 1, wherein the second tube fullyencircles a circumference of the first tube.
 4. The tracheal tube systemof claim 1, wherein the first open end of the first tube is configuredto be coupled to an artificial ventilation device.
 5. The tracheal tubesystem of claim 1, wherein the second tube is positioned coincident witha junction between the inflatable balloon and the first tube, thejunction being positioned between the first open end of the first tubeand the inflatable balloon.
 6. The tracheal tube system of claim 1,wherein, when the tracheal tube system is placed in the trachea, thenegative pressure created by the suction device acts to suck fluid fromthe trachea through the multiplicity of holes in the second tube,thereby evacuating the fluid from the trachea.
 7. The tracheal tubesystem of claim 1, wherein the second tube is positioned such that whenthe tracheal tube system is inserted into the trachea of a patient andnegative pressure is applied to the second tube by the suction device,the second tube is positioned against a posterior portion of the tracheawall.
 8. The tracheal tube system of claim 1, wherein the second tube isaffixed to the first tube via at least one of a bond, a sleeve, a clip,a strap, and a clamp.
 9. The tracheal tube system of claim 1, whereinthe first tube has a lumen coupled to the suction device and negativepressure in the lumen causes negative pressure in the second tube. 10.The tracheal tube system of claim 1, wherein the second tube isflexible.
 11. A tracheal tube system comprising: a first tube that isflexible and hollow and having a first open end and a second open end;an inflatable balloon affixed to and encircling an exterior portion ofthe first tube, the inflatable balloon being positioned between thefirst open end and the second open end of the first tube; and a secondtube positioned on an exterior surface of the first tube so that aportion of the second tube extends partially around a circumference ofthe inflatable balloon and is substantially perpendicular to the firsttube, the second tube being hollow and having a multiplicity of holesalong a sidewall, wherein the second tube is positioned on theinflatable balloon such that when the tracheal tube system is insertedinto a trachea, the inflatable balloon is inflated, and a negativepressure is applied to the second tube by a suction device, the secondtube is positioned against a portion of a tracheal wall.
 12. Thetracheal tube system of claim 11, wherein the second tube is curved. 13.The tracheal tube system of claim 11, wherein the second tube extendsfully around a circumference of the first tube.
 14. The tracheal tubesystem of claim 11, wherein the first open end of the first tube isconfigured to be coupled to an artificial ventilation device.
 15. Thetracheal tube system of claim 11, wherein the second tube is positionedcoincident with a junction between the inflatable balloon and the firsttube, the junction being positioned between the first open end of thefirst tube and the inflatable balloon.
 16. The tracheal tube system ofclaim 11, wherein, when the tracheal tube system is placed in thetrachea, the negative pressure created by the suction device acts tosuck fluid from the trachea through the multiplicity holes in the secondtube, thereby evacuating the fluid from the trachea.
 17. The trachealtube system of claim 11, wherein the portion of the tracheal wall is aposterior portion of the trachea wall.
 18. The tracheal tube system ofclaim 11, wherein the second tube is affixed to the first tube via atleast one of a bond, a sleeve, a clip, a strap, and a clamp.